Efficacy and Safety of the Angionix Balloon in Patients With Coronary Artery Disease Undergoing PTCA

NCT07869602 · tracked via the Priya Life Science South Korea tracker

Sponsor

Yonsei University

Phase

Observational

Started

2026-11-09

Last updated

2026-10-09

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Angionix Balloon

Angionix Balloon: Percutaneous transluminal coronary angioplasty (PTCA) balloon dilatation catheter (Angionix Balloon and Angionix NC Balloon) used for lesion preparation and post-stent dilation in patients with coronary artery disease. Balloon dilatation is performed at nominal pressure or higher for approximately 5 to 10 seconds according to standard clinical procedure.

Study summary

A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Adult aged 19 years or older at baseline 2. Patients diagnosed with coronary artery disease 3. Patients requiring percutaneous transluminal coronary angioplasty (PTCA) with Angionix Balloon or Angionix NC Balloon 4. Patients who voluntarily agree to participate in this study and sign an informed consent form Exclusion Criteria: 1. Patients presenting with cardiogenic shock based on the investigator's clinical judgment 2. Patients with vessel dissection already identified on coronary angiography prior to PTCA procedure based on the investigator's clinical judgment 3. Pregnant or lactating women 4. Patients who have other clinically significant findings that make them unsuitable for study participation based on the investigator's medical judgment

Primary outcome measure(s)

Successful lesion expansion with Angionix Balloon — During the procedure (immediately after balloon dilatation)
Successful lesion expansion is defined as achievement of less than 50% stenosis of the original vessel diameter in the target stenotic lesion treated with Angionix Balloon.

Trial sites (3)

Facility	City	Region
Yongcheol Kim	Yongin	Gyeonggi-do
Kyungpook National University College Hospital	Daegu	Gyeongsangnam-do
Jeonbuk National University Hospital	Jeonju	Jeollabuk-do

More Yonsei University trials in South Korea

Concurrent Neoadjuvant Chemoradiotherapy Plus Durvalumab (MEDI4736) in Resectable Stage III NSCLC Recruiting

Aspirin vs Clopidogrel After TAVR Recruiting

Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers Recruiting

Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC) Recruiting

Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application Active, not recruiting

Other trials for the same condition

Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease Active, not recruiting

The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique Recruiting

CREATE Trial, Prospective, Observational Study Active, not recruiting

Study of the Natural History of FFR Guided Percutaneous Coronary Intervention Recruiting

Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07869602 on ClinicalTrials.gov ↗ ← All trials in South Korea